Patients treated with regorafenib showed poor adherence to topical moisturizing preparations for the prevention and management of hand-foot skin reaction (HFSR). The findings from this study were published in the Journal of Oncology Pharmacy Practice.
Hand-foot skin reaction is a known adverse effect of treatment with regorafenib, a small molecule multi-targeted kinase inhibitor approved by the US Food and Drug Administration (FDA) for the treatment of patients with metastatic colorectal cancer, gastrointestinal stromal tumor, and hepatocellular carcinoma. Furthermore, hand-foot skin reaction is one of the most clinically significant toxicities of treatment with regorafenib. Grade 3 hand-foot skin reaction has been reported to occur in more than 20% of patients enrolled in some clinical trials of regorafenib, resulting in dose reductions and treatment interruptions, even at lower-grade toxicity. Supportive care measures that help prevent and manage hand-foot skin reaction include the prophylactic use of topical urea-based moisturizing ointments.
“This study is the first to report on the adherence of cancer patients to the use of a topical ointment as supportive care and the factors influencing adherence,” the authors stated.
This retrospective analysis included data for patients with colorectal cancer treated with regorafenib at a single cancer center in Japan between April 2013 and June 2017. Patient adherence to the recommended ointment was evaluated through weekly assessments of the amount of ointment remaining in the container and comparisons with recommendations for its use included in the patient medical record.
Of the 118 patients with advanced colorectal cancer who received treatment with regorafenib, excluding those who discontinued the treatment before 14 days or were still receiving active treatment, the median duration of administration was 64 days. The median time to first dose reduction was 28 days, although none of these patients underwent a first reduction in dose due to hand-foot skin reaction.
A key finding from this study was that poor adherence to the prescribed topical ointment, defined as use of less than 21 grams/week, was reported in 36% of patients. On multivariate analysis, poor adherence to the topical ointment was associated with full-time working status (P =.023), and improved adherence was associated with grade 2 or higher hand-foot skin reaction (P <.001).
Interestingly, an association with good adherence and prevention of hand foot skin reaction could not be demonstrated in this study.
Study limitations included the lack of validation of the cutoff separating the good from the poor adherence groups, the possibility of selection bias given the small number of patients from a single institution, as well as the retrospective nature of the study which precluded direct patient interviews.
The study authors reported that motivating patients to improve adherence to regimens with moisturizing ointments will be problematic.
Sato J, Ishikawa H, Hamauchi S, et al. Adherence to a topical moisturizing preparation for regorafenib-related hand-foot reaction [published online May 19, 2019]. J Oncol Pharm Pract. doi: 10.1177/107815521984927